PREVENTION OF EARLY ASTHMA IN KIDS (PEAK)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。哮喘是儿科年龄组公共卫生面临的最重要挑战之一。不仅这种疾病的患病率在增加，特别是在上学早期，而且儿童哮喘给卫生保健系统带来的经济负担也在增加。虽然有治疗哮喘的有效方法，但证明这种治疗可以改变疾病的自然进程的证据是有限的。本研究的主要目的是确定早期干预吸入抗炎药是否可以预防哮喘高风险幼儿随后出现明显的哮喘症状。该研究将比较吸入氟替卡松（一种吸入性皮质激素）与安慰剂在2至4岁哮喘高危儿童中改变哮喘病程的效果。将有四周的磨合期来对儿童进行资格鉴定和定性。儿童将被随机分为两个治疗组；一组接受积极治疗，另一组接受安慰剂。这些儿童将接受为期24个月的持续治疗，随后是为期一年的观察期，以评估哮喘症状的模式。本研究有三个具体目标：1)评估如果连续吸入糖皮质激素治疗儿童发起4年或更少高患哮喘的风险可以防止重要的哮喘的发展在4到6岁,2)来确定这哮喘治疗可以防止损失肺功能及气道敏感性的发展与早发性哮喘有关,和3)来评估潜在的副作用,可能与长期吸入类固醇在生命早期的使用。如果这种治疗方法有效，它将改变我们在儿童早期治疗哮喘的方式。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Asthma is one of the most important challenges to public health in the pediatric age group. Not only is the prevalence of the disease increasing, especially during the early school years, but the financial burden of childhood asthma on the health care system is also on the rise. Although effective therapy is available for the treatment of asthma, the evidence that such treatment can change the natural course of the disease is limited. The main purpose of this study is to determine if early intervention with inhaled anti-inflammatory agents in young children at high risk for the development of asthma may prevent the subsequent development of significant asthma symptoms. The study will compare the effects of inhaled fluticasone, an inhaled corticosteriod, to placebo in children 2 to 4 years of age at high risk of developing asthma, on altering the course of asthma. There will be a four-week run-in period to qualify and characterize children. Children will be randomized to one of two treatment groups; one receiving active treatment, the other placebo. The children will receive continuous treatment for a period of twenty-four months, followed by an observation period of one year that will assess the pattern of asthma symptoms. There are three specific objectives of this study: 1) To assess if continuous treatment with inhaled corticosteroids initiated in children 4 years or less at high risk of developing asthma can prevent the development of significant asthma at four to six years of age, 2) To determine if this asthma therapy can prevent both losses lung function and the development of airway sensitivity associated with early onset asthma, and 3) To assess potential side effects that may be associated with long term use of inhaled steroids in early life. If this treatment is effective, it will change the way we manage asthma in early childhood.